The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue

Deep Caries Clinical Trial

Official title:

The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816525
• Other study ID #: PARTIALCARIESREMOVAL
• Status: Recruiting
• Start date: April 21, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Helsinki
• Contact: Katri Croft, DDS
• Phone: +358407367250
• Email: katri.croft[@]helsinki.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. The main questions the study aims to answer are:

• Do preoperative symptoms affect the outcome?

• Does the depth of the carious lesion affect the outcome?

One hundred participants will be recruited. Patients who meet the eligibility criteria will be asked to give their informed consent to participate in the study. Partial carious tissue removal will be performed regardless of participation in the study because selective carious tissue removal is the standard treatment of choice for a vital tooth with a deep carious lesion according to the Finnish national treatment guidelines. Participants will be asked to fill in a questionnaire regarding symptoms 7 days post-treatment. The teeth will then be followed up for 12-24 months.

The null hypothesis is that there is no difference in the success between i) deep and extremely deep carious lesions and ii) initial and mild pulpitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• the patient is communicating in the Finnish or English language

• a deep primary or secondary carious lesion in 1st or 2nd premolar or molar on occlusal or proximal surface, extending to the deepest quarter of dentine assessed from the radiograph

• asymptomatic or symptoms not more severe than reversible pulpitis (mild pulpitis according to the new pulpitis classification proposal)

• pulp responding to the electric pulp testing and cold testing

• the periodontal stage of the tooth should be I or II.

In case the patient has several teeth fulfilling the inclusion criteria, the one with the deepest lesion and/or most severe symptoms is chosen to the study.

Exclusion Criteria:

• general medical condition which makes the patient more susceptible to odontogenic infection complications

• pregnancy, breastfeeding

• mental retardation, memory disorder

• the carious lesion is extending to more than three surfaces or to both proximal surfaces

• the tooth has previous other filling(s): i) extending deeper than to the outer third of dentine; or ii) the filling is larger than Class I or II; or iii) Class II filling is not restricted to enamel; or iv) the filling has secondary/residual caries

• the tooth is not restorable

• periapical changes in the periapical radiograph

• sensitivity to percussion; swelling; sinus tract; increased mobility; resorption

• furcal lesion more severe than Class I

• ongoing orthodontic treatment

• declining to sign the written consent.

Related Conditions & MeSH terms

• Deep Caries
• Hyperemia
• Pulpitis

Intervention

Procedure:
• Partial removal of carious tissue
Nonselective carious tissue excavation will be performed in the periphery of the cavity to achieve a good marginal seal. In the pulpal wall selective, partial carious tissue excavation is performed to the soft dentin, removing tissue only the amount that is necessary for placing the restoration. The tooth is restored with high-viscosity glass-ionomer cement.
• Final restoration
The teeth will be restored with composite resin after 12 months follow up, if the tooth is asymptomatic, responds to sensibility tests and there are no periapical changes radiographically. Glass ionomer cement will be only partially removed to create space for the final restoration.

Locations

Country	Name	City	State
Finland	Western Uusimaa Wellbeing Services County	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
University of Helsinki

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and radiographic success at the follow up	Symptoms and the clinical condition of the tooth will be evaluated at the follow up. In particular, the response of the tooth to both cold and EPT will be tested. In addition, a periapical radiograph will be taken. An asymptomatic tooth that responds positively to sensibility testing (both cold and EPT) and has no signs of infection clinically or in a periapical radiograph, is considered a success.	12-24 months
Secondary	Symptoms 7 days post-treatment	The participants will be asked to fill in an electronic questionnaire 7 days after the partial carious tissue removal. The participants will be asked whether the tooth was asymptomatic or symptomatic i) pre-treatment and ii) on the day of treatment after local anesthesia, iii) 3 days post-treatment and iv) 7 days post-treatment. Multi-choice questions will be used to find out about the nature and intensity of pain.	7 days
Secondary	Pain severity using Visual Analogue Scale (VAS) 7 days post-treatment	The participants will be asked to fill in an electronic Visual Analogue Scale (VAS) 7 days after the partial carious tissue removal. VAS will be used to assess the severity of pain experienced. The scale will be 0-10, 0 indicating no pain and 10 indicating worst pain imaginable. The participants will be asked about pain severity i) pre-treatment, ii) on the day of treatment after local anesthesia, iii) 3 days post-treatment and iv) 7 days post-treatment.	7 days